Cleared Traditional

K893877 - BIOCHEM 3100 OXIMETER

K893877 is an FDA 510(k) clearance for BIOCHEM 3100 OXIMETER, manufactured by Biochem International, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K893877 · Biochem International, Inc. · Cardiovascular device
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Dec 1989
Decision
208d
Days
Class 2
Risk

K893877 is an FDA 510(k) clearance for the BIOCHEM 3100 OXIMETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Biochem International, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 20, 1989 after a review of 208 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochem International, Inc. devices

FDA 510(k) Submission Details - K893877

510(k) Number K893877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1989
Decision Date December 20, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 365
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K893877.
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741 · Schneider Intl., Ltd. · Feb 1990
GUIDING CATHETER
K895146 · Peripheral Systems Group · Jan 1990
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · Baxter Healthcare Corp · Nov 1989
ARROW HANDS-OFF THERMO-PACE
K895268 · Arrow Intl., Inc. · Nov 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · Boston Scientific Corp · Aug 1989